Application 091076
- Type
- ANDA
- Sponsor
- NOVEL LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIAZEPAM | DIAZEPAM | GEL;RECTAL | 10MG/2ML (5MG/ML) | No | No |
| 002 | DIAZEPAM | DIAZEPAM | GEL;RECTAL | 20MG/4ML (5MG/ML) | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 74534 | ORIG | 2023-06-16 |